Investing.com -- Cogent Biosciences Inc (NASDAQ:COGT) stock rose 3.4% Monday after the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its bezuclastinib treatment in combination with sunitinib for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib.
The designation, which is intended to expedite the review process for medicines that show potential for substantial improvement over available therapies, was based on results from the company’s PEAK trial. The study demonstrated that the bezuclastinib combination reduced the risk of disease progression or death by 50% compared to the current standard of care.
"We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer.
The FDA previously agreed to accept Cogent’s New Drug Application (NDA) under the Real-Time Oncology Review program, which allows for pre-submission of components to expedite the review process. The company remains on track to complete its NDA submission in April 2026.
Median progression-free survival in the PEAK trial was 16.5 months for the bezuclastinib combination versus 9.2 months for sunitinib monotherapy. The company plans to present full results from the trial at a major medical meeting during the first half of 2026.
Cogent also expects to initiate a Phase 2 trial in mid-2026 investigating the treatment combination for first-line GIST patients with exon 9 mutations.
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